GLAD SKIN ECZEMA CREAM- colloidal oatmeal lotion
Prime Enterprises

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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GLADSKIN ECZEMA- colloidal oatmeal cream

Active Ingredient

Colloidal Oatmeal 0.02%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin iritation and itching due to eczema.

Warnings

For external use only.

When using this product do not get into eyes.

Stop use and ask a doctor if:

Conditions worsen
Symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

Apply twice daily, or more as desired, on skin free of other products.
Let the cream absorb into skin for 5 minutes before applying other products.

Inactive Ingredients

Water, Glycerin, Petrolatum, Mineral Oil, Cetearyl Alcohol, Ceteareth-20, Arginine HCl, Sodium Chloride, Trometamol, Calcium Chloride, sr-(Methionyl Staphylococcus Simulans Polypeptide-1 Dipeptide-53 Staphylococcus Phage 2638A Polypeptide-1)

Questions

hello@gladskin.com

Principle Display Label - Gladskin Eczema Cream 50 mL

Principle Display Label

GLAD SKIN ECZEMA CREAM
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0548
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.175 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
TROMETHAMINE (UNII: 023C2WHX2V)
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white (Off White)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0548-3	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/06/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	12/06/2019

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprise		101946028	pack(58443-0548) , manufacture(58443-0548) , analysis(58443-0548) , label(58443-0548)